EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2011) final 
Draft 
COMMISSION DIRECTIVE 
of 
amending Annex I to Directive 2001/37/EC of the European Parliament and of the 
Council on the approximation of the laws, regul ations and administrative provisions of 
the Member States concerning the manufactu re, presentation and sale of tobacco 
products 
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION DIRECTIVE 
of 
amending Annex I to Directive 2001/37/EC of the European Parliament and of the 
Council of on the approximation of the laws, regulations and administrative provisions 
of the Member States concerning the manufac ture, presentation and sale of tobacco 
products 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2001/37/EC of the Eur opean Parliament and th e Council of 5 June 
2001 on the approximation of the laws, regulati ons and administrative provisions of the 
Member States concerning the manufacture, presentation and sale of tobacco products
1, and in 
particular Article 9(2) thereof, 
Whereas: (1) Article 5(2)(b) of Directive 2001/37/EC provi des that each unit packet of tobacco 
products, except for tobacco for oral use and other smokeless tobacco products, and 
any outside packaging, with the exception of additional transparent wrappers, must 
carry an additional warning from the list set out in Annex I to that Directive. 
(2) Those additional warnings have been manda tory on all packages of smoking tobacco 
since September 2003 and on packages of other tobacco products since September 
2004.  
(3) Evidence suggests that the impact of current additional warnings set out in Annex I to 
Directive 2001/37/EC has decreased over time  as the novelty effect of the warning 
messages has worn off.  
(4) In addition, new scientific evidence on the health effects of tobacco use and the 
principles of effective tobacco labelling ha s emerged since the adoption of Directive 
2001/37/EC. In particular, there is evidence that smoking play s a causal role in mouth 
and throat cancer, visual impairments as well  as dental and gum disease. There is also 
evidence that parental smoking is a majo r risk factor for smoking initiation. 
(5) Article 9(b) of Di rective 2001/37/CE provides that the Commission shall adapt to 
scientific and technical progress the health warnings set out in Annex I of the same 
                                                
 
1 OJ L 194, 18.7.2001, p. 26.  
EN 3   EN Directive. Furthermore, Guidelines  on tobacco packaging and labelling2 adopted by 
the Third Conference of the Parties to the WHO Framework Convention on Tobacco 
Control in November 2008 recommend that  legal measures for packaging and 
labelling of tobacco products should be reviewed periodically and updated as new evidence emerges and as specific hea lth warnings and messages wear out. 
(6) A revision of the current additional warn ings set out in Annex I to Directive 
2001/37/EC is therefore needed in order to maintain and increase their impact, and to 
take into account the new scientific developments. 
(7) This revision should be based on the results  of the review of existing knowledge on 
tobacco labelling and the health  effects of tobacco use and of testing of the warnings 
made in all Member States. 
(8) The measures provided for in this Directiv e are in accordance with the opinion of the 
Regulatory Committee established under Arti cle 10(1) of Directive 2001/37/EC and 
neither the European Parliament nor the Council has opposed them, 
HAS ADOPTED THIS DIRECTIVE:  
Article 1 
Annex I to Directive 2001/37/EC is replaced by the text in the Annex to this Directive. 
Article 2 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by […] (two years of the entry into force of this Directive) at the latest. They shall forthwith communicate to the Commission the text of those provisions  and a correlation table between those 
provisions and this Directive. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official 
publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 3 
Member States may decide to allow the conti nuation of marketing of products not complying 
with the provisions of this Directive until […] (four years of the entry into force of this 
Directive). 
                                                
 
2 FCTC/COP3(10) Guidelines for implementation of Article 11 of the WHO Framework Convention on 
Tobacco Control (Packaging and labelling of tobacco products)  
EN 4   EN Article 4 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 5 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 The President   
 […]   
ANNEX
 
“ANNEX I 
List of additional health warnings 
(referred to in Article 5(2)(b)) 
(1) Smoking causes 9 out of 10 lung cancers  
(2) Smoking causes mouth and throat cancer  
(3) Smoking damages your lungs  
(4) Smoking causes heart attacks  
(5) Smoking causes strokes and disability  
(6) Smoking clogs your arteries  
(7) Smoking increases the risk of blindness  
(8) Smoking damages your teeth and gums  
(9) Smoking can kill your unborn child  
(10) Your smoke harms your children, family and friends  
(11) Smokers' children are more likely to start smoking 
(12) Quit smoking – stay alive for those close to you3  
                                                 
3 To be completed by a reference to the telephone/internet address of the quit lines/cessation services if 
existing in the Member State concerned.  
EN 5   EN (13) Smoking reduces fertility 
(14) Smoking increases the risk of impotence